Efficacy and Safety of VDPHL01 in Males with AGA

Last updated: March 20, 2025
Sponsor: Veradermics, Inc.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Male Pattern Baldness

Alopecia

Hair Loss

Treatment

Placebo

VDPHL01

Clinical Study ID

NCT06724614
250-13951-302
  • Ages 18-65
  • Male

Study Summary

This study will evaluate the safety and efficacy of VDPHL01 in male subjects with Androgenetic Alopecia (AGA).

AGA (or male pattern baldness) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablet is an investigational oral drug to treat male pattern baldness.

This multi-center, double blind, study will last about 13 months and includes 11 study visits (screening, baseline (day 1), week 2, month 1, month 2, month 4, month 6, month 8, month 10, month 12, month 13).

The first 7 visits will be part of the placebo-controlled period. The next 3 visits will be part of the treatment extension phase. All subjects will receive active drug in the treatment extension phase.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is male aged 18-65 years old;

  • Subject has a clinical diagnosis of mild to moderate AGA;

  • Subject is in good general health and has normal renal and hepatic function;

  • Subject is willing to maintain at least 1/4 inch length hair during the study withthe same hairstyle, hair length, and hair color throughout the study; maintainconsistent use of general hair care products and regimen through the entire study;

  • Subject is willing and able to administer the test article as directed read,understand, and complete required questionnaires in English;

  • Subject is willing and able to swallow study drug whole;

  • Subject agrees to have a micro dot tattoo placed on their scalp;

  • Subject agrees to have this area photographed at study visits as indicated in theprotocol.

Exclusion

Exclusion Criteria:

  • Subject has uncontrolled blood pressure;

  • Subject has symptoms or history of certain heart or thyroid conditions;

  • Subject has a history of cardiac and/or thyroid diseases;

  • Subject has received an organ transplant;

  • Subject has a history of prescription drug abuse or illicit drug use within 6 monthsof screening; history of alcohol abuse within 6 months prior to screening;

  • Subject has a current or recent history of dietary or weight changes;

  • Subject has been diagnosed with COVID-19 within 16 weeks of baseline;

  • Subject has used any topical scalp treatments for hair growth within 4 weeks priorto screening;

  • Subject has had any scalp procedures, including surgical, laser, light or energytreatments, micro-needling, etc. within 6 months prior to screening

  • Subject has had previous radiation of the scalp

  • Subject has used systemic cimetidine, ketoconazole, diazoxide, or corticosteroids (including intramuscular, intraarticular, and intralesional injections) within 12weeks prior to screening

  • Subject has used systemic beta blockers within 12 weeks prior to screening

  • Subject is currently enrolled in an investigational drug, biologic, or device studyor has used an investigational treatment within 30 days prior to screening

  • Subject has used any other therapy with any medication either topical or oral thatmight, in the investigator's opinion, interfere with the study

Study Design

Total Participants: 480
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
November 06, 2024
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Site 36

    Birmingham, Alabama 35203
    United States

    Active - Recruiting

  • Site 28

    Phoenix, Arizona 85018
    United States

    Active - Recruiting

  • Site 30

    Fort Smith, Arkansas 72916
    United States

    Active - Recruiting

  • Site 35

    Rogers, Arkansas 72758
    United States

    Active - Recruiting

  • Site 07

    Fountain Valley, California 92728
    United States

    Active - Recruiting

  • Site 02

    Fremont, California 94538
    United States

    Active - Recruiting

  • Site 34

    Sherman Oaks, California 91403
    United States

    Active - Recruiting

  • Site 21

    Vista, California 92083
    United States

    Active - Recruiting

  • Site 05

    Castle Rock, Colorado 80109
    United States

    Active - Recruiting

  • Site 24

    Englewood, Colorado 80111
    United States

    Active - Recruiting

  • Site 17

    Aventura, Florida 33180
    United States

    Active - Recruiting

  • Site 25

    Brandon, Florida 33511
    United States

    Active - Recruiting

  • Site 42

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • Site 03

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Site 43

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

  • Site 31

    Boise, Idaho 83704
    United States

    Active - Recruiting

  • Site 23

    Rolling Meadows, Illinois 60008
    United States

    Active - Recruiting

  • Site 15

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • Site 32

    New Albany, Indiana 47150
    United States

    Active - Recruiting

  • Site 27

    West Lafayette, Indiana 47906
    United States

    Active - Recruiting

  • Site 41

    Baton Rouge, Louisiana 70809
    United States

    Active - Recruiting

  • Site 13

    Covington, Louisiana 70433
    United States

    Active - Recruiting

  • Site 12

    Metairie, Louisiana 70006
    United States

    Active - Recruiting

  • Site 22

    Brighton, Massachusetts 02135
    United States

    Active - Recruiting

  • Site 26

    Clarkston, Michigan 48346
    United States

    Active - Recruiting

  • Site 06

    New Brighton, Minnesota 55112
    United States

    Active - Recruiting

  • Site 18

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Site 37

    Kew Gardens, New York 11415
    United States

    Active - Recruiting

  • Site 38

    New York, New York 10075
    United States

    Active - Recruiting

  • Site 39

    Boardman, Ohio 44512
    United States

    Active - Recruiting

  • Site 11

    Columbus, Ohio 43215
    United States

    Active - Recruiting

  • Site 08

    Broomall, Pennsylvania 19073
    United States

    Active - Recruiting

  • Site 10

    Plymouth Meeting, Pennsylvania 19462
    United States

    Active - Recruiting

  • Site 20

    Greensville, South Carolina 29615
    United States

    Active - Recruiting

  • Site 09

    Knoxville, Tennessee 37909
    United States

    Active - Recruiting

  • Site 16

    Murfreesboro, Tennessee 37130
    United States

    Active - Recruiting

  • Site 04

    Nashville, Tennessee 37215
    United States

    Active - Recruiting

  • Site 40

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Site 44

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Site 14

    Houston, Texas 77056
    United States

    Active - Recruiting

  • Site 19

    West Jordan, Utah 84095
    United States

    Active - Recruiting

  • Site 29

    Lynchburg, Virginia 24501
    United States

    Active - Recruiting

  • Site 33

    Seattle, Washington 98168
    United States

    Active - Recruiting

  • Site 01

    Spokane, Washington 99202
    United States

    Active - Recruiting

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